Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021136
Company: CHIRHOCLIN
Company: CHIRHOCLIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SECREFLO | SECRETIN SYNTHETIC PORCINE | 16MCG/VIAL | FOR SOLUTION;INTRAVENOUS | Discontinued | None | No | No |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/26/2016 | SUPPL-13 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013_021209s002lbl.pdf | |
| 10/26/2016 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013_021209s002lbl.pdf | |
| 11/01/2002 | SUPPL-1 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21136s1lbl.pdf | |
| 04/04/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21136lbl.pdf |